Capacity to informed consent to diagnostics and treatment of patients in early stages of Alzheimer's Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023840

Enrollment

Registered

2021-01-04

Start date

2021-01-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F00

Interventions

Group 1: MacCAT-T-Interview with 20 patients in early stages of Alzheimer’s disease, twice over a time period of a few months (T0 and T1) Group 2: MacCAT-T-Interview (through supporting material modif

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with Alzheimer’s Disease at an early stage (2) Patients capable to informed consent at the time of their inclusion in the study (medical evaluation, according to AMG) (3) Reference group: Relatives of AD-Patients without cognitive impairments, who have comparable levels of information and knowledge about the disease

Exclusion criteria

Exclusion criteria: (1) Inadequate knowledge of the German language

Design outcomes

Primary

Measure	Time frame
Evaluation of how supportive measures for disease-related impairment can improve informed consent of patients with early-stage Alzheimer’s disease by applying the MacCAT-T. Consequently, the aim is to provide support for informed consent and self-reliant living of patients with AD through decisions made by experts. The capacity to informed consent is assessed with the evaluation scales of the MacCAT-T tool developed by Grisso/Appelbaum, which was translated into German and fitted to specific needs of patients with AD by J. Vollmann. It assesses four different criteria (the ability to understand information given to the patients, appreciation (of disorder and treatment), reasoning, expressing a choice). Patients’ responses are rated by scales, which can be summed up and divided by the number of individual answers. If the summarized evaluation for a patient with AD is the same or higher than the average of the control group, it can be assumed that the patient with AD has a sufficient capability to informed consent. By comparing the achieved scores of patients from two points of time, t-tests (group comparisons) can be used to determine the extent to which supportive material leads to a significant increase in the responses of a group of 20 AD patients. In the long term, this provides insight into how the utilization of specific material, as for example visual aids, can support the assessment of patients with AD. Analysis were conducted with the help of the software Statistical Package for the Social Sciences (SPSS).	—

Measure

Time frame

Evaluation of how supportive measures for disease-related impairment can improve informed consent of patients with early-stage Alzheimer’s disease by applying the MacCAT-T. Consequently, the aim is to provide support for informed consent and self-reliant living of patients with AD through decisions made by experts. The capacity to informed consent is assessed with the evaluation scales of the MacCAT-T tool developed by Grisso/Appelbaum, which was translated into German and fitted to specific needs of patients with AD by J. Vollmann. It assesses four different criteria (the ability to understand information given to the patients, appreciation (of disorder and treatment), reasoning, expressing a choice). Patients’ responses are rated by scales, which can be summed up and divided by the number of individual answers. If the summarized evaluation for a patient with AD is the same or higher than the average of the control group, it can be assumed that the patient with AD has a sufficient capability to informed consent. By comparing the achieved scores of patients from two points of time, t-tests (group comparisons) can be used to determine the extent to which supportive material leads to a significant increase in the responses of a group of 20 AD patients. In the long term, this provides insight into how the utilization of specific material, as for example visual aids, can support the assessment of patients with AD. Analysis were conducted with the help of the software Statistical Package for the Social Sciences (SPSS).

—

Secondary

Measure	Time frame
(Further) development of specific guidelines and detailed training offers, tailored to the special needs of patients with AD, including diagnostics and treatment.	—

Countries

Germany

Contacts

Public ContactHeiner Fangerau

Institut für Geschichte, Theorie und Ethik der Medizin, Medizinische Fakultät, Heinrich-Heine-Universität Düsseldorf

heiner.fangerau@hhu.de0049 - (0)211 81 - 06458

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026